MEDI5752 in Combination with Carboplatin plus Pemetrexed in Unresectable Pleural Mesothelioma - eVOLVE-Meso
Study identifier:D7988C00001
ClinicalTrials.gov identifier:NCT06097728
EudraCT identifier:2023-000067-32
CTIS identifier:2023-503231-17-00
Recruiting
Official Title
A Phase III, Randomized, Open-Label, Multicenter, Global Study of Volrustomig (MEDI5752) in Combination with Carboplatin plus Pemetrexed Versus Platinum plus Pemetrexed or Nivolumab plus Ipilimumab in Participants with Unresectable Pleural Mesothelioma (eVOLVE-Meso)
Medical condition
Unresectable Pleural mesothelioma
Phase
Phase 3
Healthy volunteers
No
Study drug
Volrustomig, Pemetrexed, Carboplatin, Cisplatin, Nivolumab, Ipilimumab
Sex
All
Estimated Enrollment
600
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 09 Nov 2023
Estimated Primary Completion Date: 15 Mar 2027
Estimated Study Completion Date: 13 Mar 2028
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Volrustomig + Carboplatin + pemetrexed Volrustomig in combination with carboplatin plus pemetrexed | Drug: Volrustomig MEDI5752: Administered as IV infusion Other Name: MEDI5752 Drug: Pemetrexed Alimta: Administered as IV infusion Other Name: Alimta Drug: Carboplatin Paraplatin: Administered as IV infusion Other Name: Paraplatin |
| Active Comparator: Investigator's choice of standard care The investigator’s choice of nivolumab plus ipilimumab or platinum plus pemetrexed chemotherapy for participants with epithelioid histology, and nivolumab plus ipilumab for participants with non-epithelioid histology. | Drug: Pemetrexed Alimta: Administered as IV infusion Other Name: Alimta Drug: Carboplatin Paraplatin: Administered as IV infusion Other Name: Paraplatin Drug: Cisplatin Platinol: Administered as IV infusion Other Name: Platinol Drug: Nivolumab Opdivo: Administered as IV infusion Other Name: Opdivo Drug: Ipilimumab Yervoy: Administered as IV infusion Other Name: Yervoy |
Contacts
Investigators
Principal Investigator
Marjorie G Zauderer
Memorial Slone Kettering (MSK) Cancer Centre, NY
